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MTIG Position Statement for FMT

WASHINGTON, March 14, 2019 /PRNewswire/ -- The Microbiome Therapeutics Innovation Group (MTIG) announced the publication of its Position Statement on Fecal Microbiota Transplantation (FMT) treatment.

The statement supports the FDA Draft Guidance providing for patient access to FMT treatment through clinical trials or a physician-prepared setting with donor controls and informed consent. The statement is also aligned with FDA's position not to extend enforcement discretion to unregulated commercial-scale FMT stool banks that have not established safety and efficacy through FDA-regulated clinical trials.

"We welcome the opportunity to publicly state our membership's support of the FDA's expertise in this matter," said Thomas J. DesRosier, Chairman of the MTIG Board.

The Microbiome Therapeutic Innovation Group (MTIG) is an independent 501(c)(6) coalition of companies leading the research and development of FDA-approved microbiome therapeutics and microbiome-based products to address unmet medical needs, improve clinical outcomes, and reduce health care costs. The human microbiome is one of the new frontiers of medical innovation that has the potential to benefit patients suffering from numerous diseases afflicting millions of patients and consuming billions of dollars of healthcare resources. Through a collective voice, the MTIG membership works together to enhance the regulatory, investment, and commercial environment to accelerate microbiome therapeutic drug product development and expand availability of life-changing and life-saving FDA approved microbiome therapies to patients. MTIG is committed to working with stakeholders who share in our mission and seek to collaborate with patients, patient advocates, professional societies/organizations/public health officials, scientists, government policymakers, healthcare providers and payers who seek tangible policy and regulatory solutions to issues in the emerging microbiome arena.

Today, the MTIG is comprised of three companies: Rebiotix, Inc., Seres Therapeutics, and Vedanta Biosciences.

About Rebiotix Inc.

Rebiotix, Inc. which is part of the Ferring Pharmaceuticals Group, is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of debilitating diseases. Rebiotix possesses a deep and diverse clinical pipeline, with its lead drug candidate, RBX2660, in Phase 3 clinical development for the prevention of recurrent Clostridium difficile (C. diff) infection. RBX2660 has been granted Fast Track status, Orphan Drug and Breakthrough Therapy designation from the FDA for its potential to prevent recurrent C. diff infection. Rebiotix's clinical pipeline also features RBX7455, a lyophilized non-frozen, oral capsule formulation, which is entering a Phase 2b clinical trial for the prevention of recurrent C. diff infection. In addition, Rebiotix is targeting several other disease states with drug products built on its pioneering Microbiota Restoration Therapy™ platform. The MRT™ platform is a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad consortium of live microbes into a patient's intestinal tract via a ready-to-use and easy-to-administer format.

Seres Therapeutics, Inc. is a leading microbiome therapeutics platform company developing a novel class of biological drugs that are designed to treat disease by restoring the function of a dysbiotic microbiome, where the state of bacterial diversity and function is imbalanced. Seres' lead program, SER-109, has obtained Breakthrough Therapy and Orphan Drug designations from the U.S. Food and Drug Administration and is in Phase 3 development for multiply recurrent C. difficile infection. Seres' clinical candidate SER-287 has successfully completed a Phase 1b study in patients with mild-to-moderate Ulcerative Colitis. Seres is developing SER-262in a Phase 1b study in patients with primary C. difficile infection. Seres is also developing SER-401 to augment the efficacy of immuno-oncology treatment.

Vedanta Biosciences is a clinical-stage company developing a new category of therapies for immune-mediated and infectious diseases based on rationally defined consortia of human microbiome-derived bacteria. An affiliate of PureTech Health (PureTech Health PLC), Vedanta Biosciences is a leader in the microbiome field with capabilities and deep expertise to discover, develop, and manufacture live bacteria drugs. These include what is believed to be the largest collection of human microbiome-associated bacterial strains, a suite of proprietary assays to select pharmacologically potent strains, vast proprietary datasets from human interventional studies, and facilities for cGMP-compliant manufacturing of rationally-defined bacterial consortia in powder form. Vedanta Biosciences' pioneering work, in collaboration with its scientific co-founders, has led to the identification of human commensal bacteria that induce a range of immune responses - including induction of regulatory T cells, CD8+ T cells, and Th17 cells, among others. These advances have been published in leading peer-reviewed journals including Science (multiple), Nature(multiple),Cell and Nature Immunology. Vedanta Biosciences has harnessed these biological insights and its capabilities to generate a pipeline of programs in infectious disease, autoimmune disease, allergy, and immune-oncology.

The Conafay Group, led by Stephen R. Conafay, is a life-sciences government relations firm based in Washington D.C. that serves as Washington counsel and coalition manager for MTIG. The team specializes in representing life sciences companies, universities, and other organizations in the biomedical space before the federal government and associated stakeholders. Services include developing a strategy to secure federal non-dilutive funding, congressional and agency relationship building, alliance development and policy lobbying.